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| Name | Class |
|---|---|
| Beijing YouAn Hospital | OTHER |
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Compare the effect of liver transplantation (LT) plus ADV-TK gene therapy versus LT only in advanced primary hepatocellular carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LT-only | Active Comparator | patients received orthotopic LT and subsequent immunosuppression therapy |
|
| LT+ADV-TK | Experimental | ADV-TK therapy was administered in addition to orthotopic LT and subsequent immunosuppression therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADV-Tk | Drug | The first ADV-TK dose was administered during the operation; 1.0×10(12) viral particles of ADV-TK in 100 mL of 0.9% saline were injected into peritoneum tissues around the liver. The second and third ADV-TK dose was administered 60 days and 90 days after LT; 1.0×10(12) viral particles of ADV-TK in 100 mL of 0.9% saline were injected into the celiac artery (60 mL) and the superior mesenteric artery (40 mL) via femoral-artery puncture. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival, PFS | PFS was measured from the day of liver transplantation to objective recurrence (MRI or CT) or HCC-related death, whichever occurred first. | 2-year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival, OS | OS was measured from the day of liver transplantation to death. | 1-year |
| Overall survival, OS | OS was measured from the day of liver transplantation to death. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danhui Weng, Dr. | Contact | 027-83663351 | weng.dh@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Youan Hospital | Recruiting | Beijing | Beijing Municipality | 10001 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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|
| LT | Procedure | Orthotopic LT and subsequent immunosuppression therapy |
|
| 2-year |
| Time of the tumor progression,TTP | TTP was the median period from the day of liver transplantation to objective recurrence (MRI or CT). | 2-year |
| Median overall survival time | 2-year |
| 301 Military Hospital | Recruiting | Beijing | China |
|
| General Hospital of Chinese People's Armed Police | Recruiting | Beijing | China |
|
| The Third XiangYa Hospital of Central South University | Recruiting | Changsha | China |
|
| West China Hospital of Sichuan University | Recruiting | Chengdu | China |
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| The Third Affiliated Hospital,Sun Yat-sen University | Recruiting | Guangzhou | China |
|
| The First Affiliated Hospital, Zhejiang University | Recruiting | Hangzhou | China |
|
| Zhongshan Hospital of Fudan University | Recruiting | Shanghai | China |
|
| The First Affiliated Hospital of China Medical University | Recruiting | Shenyang | China |
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| The First Center Hospital of Tianjin | Recruiting | Tianjin | China |
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| The First Hospital of Xinjiang Medical University | Recruiting | Ürümqi | China |
|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |